Week of August 11th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

We cover three drug warning letters, one issued to a compounding pharmacy, one device warning letter and one in the food area that is a ‘first of its kind’.  One of the drug warning letters is issued to a firm that recovered solvents that were used in the manufacture of the API of valsartan products that contained the multiple potential carcinogens.  Note that Swiss Medic inspected the firm 6 days before FDA did and issued a report of non-compliance.

 

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DRUGS | Emcure Pharmaceuticals, Ltd

Emcure Pharmaceuticals, Ltd (Maharashtra, India) received a warning letter on August 2, 2019 based on the outcome of an inspection ending February 20, 2019.  The firm manufactures drug product.  An inspection in 2017 cited similar observations where the firm performed inadequate microbiological investigations.

Deficiencies include but are not limited to:

  • The firm did not adequately investigate sterility failures and the investigations did not have sufficient data to support conclusions.  Particularly, the firm failed to address container-closure integrity hazards including the robustness of the vial sealing process.  The warning letter identified the areas where the investigations were lacking.

DRUGS | Spectrum Laboratory Products, Inc.

Spectrum Laboratory Products, Inc. (Gardena, CA) received a warning letter on July 31, 2019 based on the outcome of an inspection ending March 12, 2019.  The firm manufactures API and repackages and relabels drugs for commercial distribution in the US.

Deficiencies include but are not limited to:

  • The firm has not identified all of their drugs on the drug listing database and thus the drugs are misbranded.
  • The firm omitted the name and address of the original manufacturer on the repackaged APIs and certificates of analysis issued to customers.  FDA states the importance of true and accurate information on CoAs and recommends that the firm read ICHQ7 guidance for clarification on these requirements.
  • FDA states that similar deficiencies have been identified at another of the firm’s sites and ‘…demonstrate that management oversight and control over the manufacture of drugs are inadequate.’  FDA recommends that the firm hire qualified consultants to assist them in coming into compliance.  Finally, FDA reminds the firm that because they sell the drug glycerin it must ensure it is tested for the contaminant DEG.

DRUGS | Lantech Pharmaceuticals Limited

Lantech Pharmaceuticals Limited (Telangana, India) received a warning letter on August 8, 2019 based on the outcome of an inspection ending March 15, 2019.  Note this inspection occurred 6 days after one by Swiss Medic that identified similar issues and resulted in a report of non-compliance (more on this below).

The firm is a contract manufacturer who manufactures API-intermediate and recovers solvent for use by sartan API manufacturers.  This is another warning letter associated with the production of valsartan APIs that contain the potential carcinogenic impurity NDEA and provides additional granularity of the issue beyond what was included in the Aurobindo warning letter.

FDA placed the firm on import alert on June 27, 2019, recommended they hire quality consultants, and restates that the firm will suspend “contract solvent recovery process” at this facility for the US market.  Further, they are reminded that their quality system does not adequately ensure accuracy and integrity of data.

Deficiencies include but are not limited to:

  • Failure to investigate quality-related customer complaints regarding the presence of NDEA in a valsartan intermediate.
  • The firm did not retain logbooks for product use and cleaning of non-dedicated storage, receiving, and solvent recovery tanks.

FiercePharma also reports on the story regarding solvent recovery as the problem.

In addition, Lantech Pharmaceuticals was the subject of a report of GMP non-compliance issued on July 10, 2019 based on the outcome of an inspection ending March 9, 2019.  The inspection was conducted by Swiss Medic authorities.  The nature of the non-compliance includes: “Risk of nitrosamine contamination of Sartans and recovered solvents and recovered intermediates was not properly addressed by the company.  This was evidenced by severe failures to ensure material traceability and to reduce risk of contamination.  Cleaning validation was found inappropriate.  Quality control showed issues in data integrity as well as equipment and reagents management.  Documentation management and storage was found inadequate.”


DEVICE | Talon, an S&S Technology Company

Talon, an S&S Technology Company (Houston, TX) received a warning letter on August 2, 2019 based on the outcome of an inspection ending March 28, 2019.  The firm manufactures a variety of Class I & II medical equipment, healthcare supplies and radiation products used for general and plastic surgery.

The deficiencies include but are not limited to:

  • CAPA reports failed to document evidence that corrective actions were verified or implemented prior to closing the CAPA.
  • The firm has not established design change procedures.  Design changes have been approved, implemented and released prior to the conduction of verification.
  • The non-conforming procedures do not document that the firm will evaluate nonconformances to include a determination for an investigation.  This is a repeat observation from an FDA inspection in 2011.
  • Batch records are not maintained, and the firm does not have device history reports and has not recorded lot/batch numbers for applicable sub-components. 
  • The firm has failed to document acceptance or rejection of incoming product.  This is also a repeat observation from an FDA inspection in 2011.
  • The firm has not established procedures for performing servicing activities.
  • Failure to establish records of acceptable suppliers, contractors, and consultants.
  • The firm does not conduct management review at defined intervals.  This is yet another repeat observation from an FDA inspection in 2011.
  • The firm does not perform audits at defined intervals.
  • The firm has failed to establish adequate procedures for training.
  • The firm has failed to adequately maintain records of document changes. 
  • Medical device listing does not include registration and listing of software as required by the regulations.

FOOD | Brodt Zenatti Holdings LLC

Brodt Zenatti Holdings LLC (Jupiter, FL) received a warning letter on July 30, 2019 based on an inspection on May 17, 2019.  This is a first-of-a-kind warning letter issued under the Foreign Supplier Verification Program implementing regulation 21CFR1 subpart L.

This warning letter is associated with an outbreak of Salmonella Concord multi-state outbreak investigation of tahini imported from Karawan Tahini and Halva, located on the West Bank.  Thus, the firm is not in compliance with Section 805 of the FD&C Act.  The product is placed on import alert 99-19.  The single deviation identified was:

  • The firm did not develop an FSVP as required by section 805 of the FD&C Act and 21CFR1 Subpart L.

Here is the FDA In Brief release from the newsroom.


COMPOUNDING PHARMACY | Prescription Dispensing Laboratories, Inc

Prescription Dispensing Laboratories, Inc (Cedar Park, Texas) received a warning letter on July 30, 2019 based on the outcome of an inspection ending May 11, 2018.  Products produced by the firm do not meet the conditions of section 503A.  No specific adulteration deficiencies citing 21CFR211 are identified, but FDA cites the firm for distribution of unapproved new drugs along with the companion deficiency of misbranded drugs.

 

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