# FDA 483 - Parker Laboratories, Inc. - June 14, 2023

Source: https://www.keypedia.com/records/483/parker-laboratories-inc/da8f9dbc-1053-48f1-b81a-c5451bb9bed3

> FDA 483 for Parker Laboratories, Inc. on June 14, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Parker Laboratories, Inc.
- Inspection Date: 2023-06-14
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Parker Laboratories, Inc. in Fairfield, NJ, a drug manufacturing facility, was inspected by the FDA from May 24 to June 14, 2023. The inspection revealed significant deficiencies in quality control and manufacturing processes for OTC drug products, including a lack of stability testing programs, inadequate batch production records, unqualified equipment, and insufficient annual quality reviews and raw material identity testing. These observations indicate a failure to ensure the identity, strength, purity, and quality of their drug products.

## Related Officers

- [Director of Clinical Training](https://www.keypedia.com/people/helen-verdel/f6caf5a8-74f5-4833-bd00-5579b369f4f9)

Company: https://www.keypedia.com/companies/parker-laboratories-inc/2be6cc66-91d5-4fed-ace2-37ca0e681a2f

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248