FDA Warning Letter: Lack of Temperature and Humidity Control

Recommendation

20-22 June 2023
Barcelona, Spain

GMP & GDP Forum 2023
Day 1, 2 and 3

On 14 March 2023, the U.S. Food and Drug Administration (FDA) has published a new Warning Letter. The document, which was already sent on 20 January 2023, is addressed to a company in Massachusetts, USA, which produces homeopathic finished drug products. It goes back to an inspection at the firm's drug manufacturing facility in July and August 2022.

Storage of Drug Products and Monitoring of Humidity

One of the violations mentioned in the Warning Letter concerns the adequate storage and warehousing of drug products. It is particularly notable that the FDA criticizes not only the lack of temperature monitoring, but also monitoring of humidity. In this regard, the Warning Letter contains the following statement:

"You failed to have adequate storage and warehousing of drug products. For example, although a supplier’s certificate of analysis (COA) for a bulk drug stated that the drug is sensitive to heat, sunlight, and moisture, you failed to monitor storage conditions for the drug, including for temperature and humidity. You also acknowledged that there were inadequate storage conditions for drug products, and for your containers and closures. The holding of drug products must be performed under appropriate conditions so that the identity, strength, quality, and purity are not affected."

Further CGMP Violations

In the Warning Letter, the FDA also lists a number of other CGMP violations. This is mainly a matter of simple, basic requirements that should be in place in every GMP facility:

• The firm failed to establish a quality unit (QU) with the responsibilities and authority to oversee the manufacture of the drug products.
• The company did not have the necessary written procedures (e.g. for documented sampling, testing of components before production).
• A program for qualifying suppliers was missing.
• No batch and control records documenting the manufacturing operations could be provided.
• No batch numbers have been assigned.

Drug Production Ceased

The problems were so serious that the company has stopped production and distribution of all drug products in the meantime. Furthermore, a voluntary nationwide recall of all drug products was issued.

For more information, see the full Warning Letter to Atlantic Management Resources LTD dba. Claire Ellen Products, which is available on the FDA website.