# FDA 483 - Reliable Rexall-A Compounding Pharmacy - March 29, 2016

Source: https://www.keypedia.com/records/483/reliable-rexall-a-compounding-pharmacy/4db07b81-5a87-4046-9ff5-f273607afeed

> FDA 483 for Reliable Rexall-A Compounding Pharmacy on March 29, 2016. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Reliable Rexall-A Compounding Pharmacy
- Inspection Date: 2016-03-29
- Product Type: Drugs
- Office Name: San Francisco District Office
- Summary: This FDA Form 483 was issued to Reliable Rexall - A Compounding Pharmacy, a producer of non-sterile drugs located at 801 Irving St, San Francisco, CA 94122-2310. The inspection was conducted from March 18, 2016, to March 29, 2016. Sam C. H. Ching, R. Ph., Pharmacist, was the individual to whom the report was issued.

Eight observations were noted:

1.  **Inadequate Investigation of Returned Product:** The firm failed to conduct an appropriate investigation into a returned Biotin 100 mg Capsules product associated with an adverse reaction (patient hospitalization). Instead of investigating as per procedures, the firm shipped the returned prescription and associated finished product lots for destruction.
2.  **Improper Expiration Date Determination:** Stability testing results are not used to determine expiration dates. The firm arbitrarily manipulated expiration dates of ingredients to extend drug product expiration dates, without new material lots or documented rationale.
3.  **Failure to Reject Non-Conforming Components:** The firm failed to reject lots of components that did not meet written specifications. Expired active and inactive raw materials and finished products were found in inventory.
4.  **Insufficient Drug Product Testing:** Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to identity and strength of each active ingredient prior to release.

## Related Officers

- [National Program Expert- Pharmacy Compounding](https://www.keypedia.com/people/lucila-b-nwatu/3d1c9670-8206-425c-bddd-32e395293042)
- [Kristin M. Abaonza](https://www.keypedia.com/people/kristin-m-abaonza/cf909da8-837d-4dfe-9ccc-288b24d7bba3)

Company: https://www.keypedia.com/companies/reliable-rexall-a-compounding-pharmacy/4783195e-b75a-47f3-9c77-1b1dd8ceec00

Office: https://www.keypedia.com/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df