# FDA 483 - BBS Pharmacy, Inc. dba B&B Pharmacy - August 18, 2015

Source: https://www.keypedia.com/records/483/bbs-pharmacy-inc-dba-bb-pharmacy/a48cadd1-f675-4648-8269-0a14d204edfb

> FDA 483 for BBS Pharmacy, Inc. dba B&B Pharmacy on August 18, 2015. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BBS Pharmacy, Inc. dba B&B Pharmacy
- Inspection Date: 2015-08-18
- Product Type: Drugs
- Office Name: Los Angeles District Office
- Summary: During an inspection from August 3 to August 18, 2015, the FDA observed multiple deficiencies at the firm.

**Facility and Operations:** The firm manufactures drug products, including sterile injectables like Trimix lot # 08032015@2, BUD 01/30/2016, using ISO 5 hoods and ISO 7/8 clean rooms.

**Violations and Observations:**

*   **Microbiological Contamination Prevention (Observation 1):** Procedures to prevent microbiological contamination of sterile drug products were not followed. A technician's hands blocked airflow over vials in an ISO 5 hood during Trimix production. The firm's policy on "Sterile Injectable Recordkeeping Requirements" (Policy # 1751.1) is deficient, lacking media fill frequency requirements. Media fills were performed on an annual basis for ISO 5 hood (b)(4) but not ISO 5 hood #1, despite the latter being used more frequently.
*   **Environmental Monitoring (Observation 2):** Aseptic processing areas lacked a system for monitoring environmental conditions. No written procedure for non-viable, viable, surface, and personnel monitoring exists. The firm had not formally conducted environmental monitoring, except for a single "for information only" test in November 2014, which yielded a positive result (1 CFU of Chaelomium globosum) from a

## Related Documents

- [483 - 2015-08-18](https://www.keypedia.com/records/483/bbs-pharmacy-inc-dba-bb-pharmacy/40d64798-eb5a-4a98-ae70-7ca0ae20656a)
- [145 - Unknown Date](https://www.keypedia.com/records/145/bbs-pharmacy-inc-dba-bb-pharmacy/6ca62290-7914-4f95-9407-fe26d445c56a)
- [STATE_REFERRAL_LETTER - 2017-05-01](https://www.keypedia.com/records/state_referral_letter/bbs-pharmacy-inc-dba-bb-pharmacy/1f5dd209-d064-4318-841a-4938189ab901)

## Related Officers

- [Investigator](https://www.keypedia.com/people/binh-t-nguyen/14ca5620-1f92-4f5d-8663-3b63814aca26)
- [Compliance Officer](https://www.keypedia.com/people/yasamin-ameri/73021772-c960-4c65-aa30-cb490866ee58)
- [Retired](https://www.keypedia.com/people/ariel-cruz-figueroa/c6ade050-dbe1-4aa3-b88f-980db51b88b0)

Company: https://www.keypedia.com/companies/bbs-pharmacy-inc-dba-bb-pharmacy/74b72298-ffda-4527-8f18-0909a579356c

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b