Atlas Pharmaceuticals, LLC — FDA Facility Profile
Atlas Pharmaceuticals, LLC is an FDA-inspected facility (FEI 3013030904) located in Phoenix, AZ, US. RegDataLab tracks 4 FDA inspections and 1 compliance action at this facility.
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What FDA found at this site
- Latest inspection
- May 21, 2021: Voluntary Action Indicated (VAI)
- Inspections on record
- 4 (1 OAI, 2 VAI, 1 NAI)
- Last OAI inspection
- Sep 26, 2017
- Warning letters
- 1 listed by FDA for this FEI, latest Sep 11, 2018
- Form 483 and inspection documents
- 2 in FDA's reading room
- Recalls as the recalling firm
- 2, latest Jun 16, 2021
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| May 21, 2021 | Voluntary Action Indicated (VAI) | Procedures for sterile drug products (21 CFR 211.113(b)) Validation lacking for sterile drug products (21 CFR 211.113(b)) Acceptance of drug products (21 CFR 211.160(b)(3)) |
| Sep 26, 2017 | Official Action Indicated (OAI) | Training , Education , Experience overall (21 CFR 211.25(a)) Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a)) Environmental Monitoring System (21 CFR 211.42(c)(10)(iv)) Procedures for sterile drug products (21 CFR 211.113(b)) and 7 more |
| May 30, 2014 | Voluntary Action Indicated (VAI) | Defined areas of adequate size for operations (21 CFR 211.42(c)) Written procedures not established/followed (21 CFR 211.67(b)) Written sanitation procedures lacking (21 CFR 211.56(b)) Failing to test for penicillin cross-contamination (21 CFR 211.176) |
| Dec 21, 2011 | No Action Indicated (NAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Jun 16, 2021 | Not yet classified | V-0138-2021 | BUPRENORPHINE, 0.6 mg/mL, (9mg/15 mL) C-III, Atlas Pharmaceuticals, LLC,
711 E. Carefree… and 2 more products Lack of Assurance of Sterility. |
| Aug 28, 2019 | Not yet classified | D-0144-2020 | Ascorbic Acid Sterile Injection Solution, 500 mg/mL, 50 mL vial, Non-Corn Source, Rx only… Labeling: Not Elsewhere Classified; product is labeled as "Non-Corn Source" however the product is from a corn source. |
Form 483s and inspection documents
- May 21, 2021: 483 on FDA.gov
- Sep 26, 2017: 483 on FDA.gov
Facility details
- Company
- Atlas Pharmaceuticals, LLC
- Location
- Phoenix, AZ (US)
- Source
- inspections