# FDA 483 - Acupac Packaging Inc - March 14, 2025

Source: https://www.globalkeysolutions.net/records/483/acupac-packaging-inc/48afab9a-468b-4b23-8d96-ac5a0660a699

> FDA 483 for Acupac Packaging Inc on March 14, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Acupac Packaging Inc
- Inspection Date: 2025-03-14
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Acupac Packaging Inc. in Mahwah, NJ, a manufacturer and repacker, was cited with two observations during an FDA inspection. The observations relate to the firm's failure to properly qualify laboratory equipment, specifically an FTIR spectroscopy instrument, and to verify the suitability of analytical testing methods used for bulk drug products. These issues indicate deficiencies in quality control and assurance practices.

## Related Documents

- [483 - 2025-08-27](https://www.globalkeysolutions.net/records/483/acupac-packaging-inc/6277301a-395e-44df-9c72-6522c33b2f2d)

## Related Officers

- [Alisha B. Patel](https://www.globalkeysolutions.net/people/alisha-b-patel/3c106dac-0e0d-41f2-9f7a-69982d4e6579)
- [Tomika L. Crafter](https://www.globalkeysolutions.net/people/tomika-l-crafter/6c8260a0-c026-496d-80f6-9c30877e8f52)
- [investigator](https://www.globalkeysolutions.net/people/anthony-j-donato/a6dd6e14-529e-4b23-9b5f-02c88afb80ae)
- [Tonika L Crafton](https://www.globalkeysolutions.net/people/tonika-l-crafton/fa4d115c-f891-45d8-9160-ddca62ac3a70)

Company: https://www.globalkeysolutions.net/companies/acupac-packaging-inc/3e58f465-31ba-4317-bdca-42e9225f26db

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