FDA Warning Letters Week of 06/28/20: OTC Products, Homeopathic Drugs, & Unapproved Vendors

This week FDA posted one warning letter to a drug firm and two to compounding pharmacies. One compounding pharmacy received a warning letter from an inspection ending in 2018, and we include the 10-observation form 483.

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Drug Warning and Untitled Letters


Homeocare Laboratories Inc

Homeocare Laboratories Inc (Yonkers, NY) received a warning letter on June 22, 2020, based on the outcome of an inspection ending December 13, 2019. The firm manufactures OTC drug products including some using potent components including progesterone, Belladonna, Aconitum Napellus, and Arsenicum album. FDA recommends the firm hire a qualified consultant to help them resolve their deficiencies. Further, the warning letter identifies unapproved new drug violations.

Deficiencies include but are not limited to:

  • The firm releases drug products without testing for identity, strength, content uniformity, or impurities. The firm responded that they no longer manufacture OTC drugs and would continue to monitor the stability of drugs in distribution for “odor, appearance, and micros.”

  • The firm did not qualify suppliers, nor did they test incoming raw materials and components.  All were accepted on the supplier CoA. The firm committed to audit one of the suppliers and employ a third-party laboratory to test components for identity. FDA did not accept this approach.  The firm also said in their response to the 483 that vendor surveys were completed and acceptable but during the inspection, the firm stated that vendors did not complete the survey and thus the firm was using components from unapproved vendors.

  • The firm failed to validate cleaning procedures. This is particularly important because potent products are manufactured using shared equipment. The firm noted they no longer produce OTC drugs, but they do continue to manufacture homeopathic drugs. FDA did not accept their response because cleaning of shared equipment when manufacture uses potentially hazardous components remains an issue.

  • The manufacturing processes of OTC drugs are not validated.


Device Warning and Untitled Letters

No letters were issued this week. 


Letters to Compounding Pharmacies and Outsourcing Facilities


Auro Pharmacies, Inc

Auro Pharmacies, Inc, dba Central Drugs Compounding Pharmacy (LaHabra, CA) received a warning letter on June 3, 2020, based on the outcome of an inspection ending August 2, 2018 (yes, that’s not a typo, and here’s the 10-observation form 483.)  The warning letter cites the adulteration of drugs, distribution of unapproved new drugs, and misbranded drug products. The complete trifecta!


Malanda, Inc dba Mandell’s Clinical Pharmacy

Malanda, Inc dba Mandell’s Clinical Pharmacy (Somerset, NJ) received a warning letter on June 9, 2020, based on the outcome of an inspection ending July 25, 2019.


BIMO, GCP and GLP Warning and Untitled Letters

No letters were issued this week. 

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