FDA Warning Letters Week of 05/24/20: Sterile Drugs, OTC Products, & Hiring of Quality Consultants

FDA continues to post warning letters to the dozens of firms that sell unapproved products to diagnose, treat, and prevent COVID-19 infections and we don’t address those here. However, this week FDA posted one letter to a fertility clinic, two to drug manufacturers, and one to a compounding pharmacy and we cover these below. 

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Drug Warning and Untitled Letters

 

Altaire Pharmaceuticals, Inc. 

Altaire Pharmaceuticals, Inc. (Aquebogue, NY) received a warning letter on March 12, 2020, based on the outcome of an inspection ending April 19, 2019. FDA identifies repeat observations from previous inspections and suggests the firm hire qualified consultants to assist them in coming into GMP compliance.

In addition to deficiencies in aseptic processing the firm also has significant data integrity deficiencies. FDA stated: Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. FDA identified what the firm needs to do in terms of data integrity remediation in their long version of the boilerplate requirements. Given the nature of the deficiencies, particularly for products that were intended to be sterile, it’s surprising that the warning letter took more than a year to issue. The firm manufactures sterile ophthalmic products, sterile OTC ophthalmic products, and homeopathic products.

Deficiencies include but are not limited to:

  • The firm failed to investigate when microbial alert limits were exceeded for environmental monitoring. Further, the data was falsified.  Values recorded as zero but when the discarded plates were retrieved, on the same day, the values were TNTC.  A previous supervisor and technician had provided instruction on falsification of data. FDA did not accept their response because it lacked detail and did not describe how the firm would remediate the extent of their unreliable records. Once again, we are seeing FDA ask for “independent assessments” indicating that they are not confident that the firm can perform the assessment function adequately.
  • The firm falsified lot release data.
  • The firm’s staff were not properly garbed to perform sterile operations.  Operators in the cleanroom had exposed skin because of ill-fitting hoods and goggles.  FDA did not accept their response because they did not address how their poor gowning practices may have impacted other batches or other products beyond the ones that were subject to the observation.
  • Equipment was not properly maintained and easily cleanable with aluminum foil and duct tape used on the filling line to prevent bottle tops from falling into the associated hopper.  The response provided to the form 483 was deemed inadequate because the firm did not provide a detailed plan for a “comprehensive assessment of the design, control, and maintenance of your aseptic processing lines and clean rooms.”

 

Samchundang Pharm Co. Ltd.

Samchundang Pharm Co. Ltd.  (Seoul South Korea) received a warning letter on May 13, 2020, based on the outcome of an inspection ending October 25, 2019. FDA acknowledges in the warning letter that the firm has stopped production of drugs for the US market, and recommends that if they intend to resume production they should hire qualified consultants to assist them in coming into C\GMP compliance. The firm is a contract manufacturer for at least some of the products, and at least some are OTC products. 

Deficiencies include but are not limited to:

  • The firm did not determine the suitability of the tests they use for sterility and bioburden for products that are distributed in the US. The firm responded that they did not perform method validation because it wasn’t a requirement in the contract. FDA reminds them they are responsible for complying with CGMPs regardless of the arrangements with their customers. In audit, FDA deemed their response inadequate because they did not assess the impact it posed to the released product that was tested without a sterility method qualification.
  • The firm did not routinely identify environmental isolates recovered from the aseptic processing area. The isolates are grouped instead by morphology and only one isolate from each morphology collection is sent out for identification. FDA also objected to their alert and action limits for personnel monitoring as being excessive and should have been essentially zero.  FDA deemed their response inadequate because they didn’t perform a comprehensive assessment and remediation for their environmental monitoring program.  
  • The firm did not ensure that staff had the necessary education, training, and experience to perform their jobs.  The firm blames laboratory shortcomings on “inadequate SOPs, software, and training.”  That pretty much covers it!  Those who perform visual inspection are not trained at routine intervals as specified in the firm’s SOP.

 

Montgomery Women’s Medical Center PC

Montgomery Women’s Medical Center PC dba Montgomery Fertility Center (Rockville, MD) received a  warning letter on May 14, 2020, based on the outcome of an inspection ending January 21, 2020. The warning letter cites deficiencies against 21 CFR 1271.

Deficiencies include but are not limited to:

  • The firm did not adequately test donated cell(s) or tissues for evidence of communicable infectious diseases. The samples were not tested for HIV-1, HCV, HBV, or West Nile Virus for example. 
  • The donor’s medical records were not reviewed for risk factors or clinical evidence of infectious disease. 

 


Device Warning and Untitled Letters

No letters were issued this week.

 


Letters to Compounding Pharmacies and Outsourcing Facilities

 

Anderson Compounding Pharmacy Inc dba Anderson Compounding Pharmacy

Anderson Compounding Pharmacy Inc dba Anderson Compounding Pharmacy (Bristol, TN) received a warning letter on January 13, 2020, based on the outcome of an inspection ending April 5, 2019. FDA states the firm has voluntarily ceased compounding of sterile drugs and implemented a voluntary recall of products within expiry on April 2, 2019. FDA cited adulteration deficiencies against the FD&C Act rather than 21CFR211.

 


BIMO, GCP and GLP Warning and Untitled Letters

No letters were issued this week. 

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