Two more OTC makers slammed with US FDA warnings

By Dan Stanton

- Last updated on GMT

The US FDA warnings sent to Chinese and Hong Kong-based firms are the latest examples of OTC makers struggling to comply with pharmaceutical standard GMP.

Both letters, sent by the US Food and Drug Administration (FDA) on February 23, highlight violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals observed during inspections of their respective plants.

Nan San (HK) Pharmaceutical Factory Limited had its facility in Kowloon, Hong Kong inspected in September 2017 and was scolded for failing to adequately test for both product contamination and the identity and strength of active ingredients.

“Your firm failed to test all batches of over-the-counter (OTC) topical liquid analgesics for conformance to their specifications before releasing each batch,”the letter​ stated.

The firm used a contract laboratory to conduct finished product testing. “Although your finished drug products contain (b)(4) active ingredients, your contract laboratory only tested for the strength and identity of one of those ingredients in the finished product testing on which you relied to release your drug products.”

Inspected in August 2017, Zhejiang Ludao Technology Co located in Taizhou, China was found to have product testing and data integrity issues.

“Your firm lacks basic laboratory controls to prevent changes to paper and electronic records for your over-the-counter (OTC) drug products. You were not able to provide analytical test data for three batches of (b)(4) spray and one batch of (b)(4). We found that you created certificates of analysis (COA) for these four batches before they were manufactured and tested,”the letter​ said.

“In addition, we found three electronic data files in the electronic recycle bin of the stand-alone HPLC system you used to test finished drug product (b)(4) spray.”

GMP clampdown

Nan San’s main business area is in traditional Chinese medicine, while Xheijang Ludo makes a range of products from cosmetics to household cleaning products to air fresheners.

The two warnings are the latest in a string sent to mostly Asian firms whose primary business is not pharmaceutical manufacturing.

As such it has been suggested cosmetic and non-pharma focused manufacturers are naïve to the strict GMP requirements require d in producing pharmaceutical products.

“Cosmetic companies that manufacture OTC drugs are getting Warning Letters from the FDA,”​​Wanda Eng, a principal consultant at PAREXEL International, recently told in-Pharmatechnologist​. “It appears that the FDA is actively enforcing cGMPs on OTC drugs. This is their next crackdown like data integrity was for the last several years.”​​

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