Anderson Compounding Pharmacy, Inc. dba Anderson Compounding Pharmacy
Form 483 issued April 5, 2019 · Bristol, Tennessee
- Inspection
- Mar 26 – Apr 5, 2019
- Investigators
- June P. Page· Xiaohui Shen
- Observations
- 4
- Pages
- 6
- FEI number
- 3014877770
In short: On April 5, 2019, FDA issued a Form 483 with 4 observations to Anderson Compounding Pharmacy, Inc. dba Anderson Compounding Pharmacy in Bristol, Tennessee (FEI 3014877770) after an inspection that ran Mar 26 – Apr 5, 2019. The investigators were June P. Page and Xiaohui Shen.
What FDA observed
Preview: the opening words of each observation- 01FDCA 501(a)(2)(A)
The ISO 5 classified aseptic processing areas had difficult to clean and visibly…
- 02FDCA 501(a)(2)(A)
Non-microbial contamination was observed…
- 03FDCA 501(a)(2)(A)
Unsealed, loose ceiling tiles were…
- 04FDCA 501(a)(2)(A)
You produced hazardous chugs without providing adequate…
This inspection in context
June P. Page
30 documents · 2015–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in India.
The firmAnderson Compounding Pharmacy, Inc. dba Anderson Compounding Pharmacy history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
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Questions about this 483
What did FDA find at Anderson Compounding Pharmacy, Inc. dba Anderson Compounding Pharmacy?
FDA listed 4 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected Anderson Compounding Pharmacy, Inc. dba Anderson Compounding Pharmacy?
June P. Page and Xiaohui Shen are named on this Form 483, for the inspection of Mar 26 – Apr 5, 2019. Each investigator has a profile showing what they cite most.
When was Anderson Compounding Pharmacy, Inc. dba Anderson Compounding Pharmacy inspected by FDA?
The inspection ran Mar 26 – Apr 5, 2019, and the Form 483 is dated April 5, 2019.
How do I get the full Form 483 for Anderson Compounding Pharmacy, Inc. dba Anderson Compounding Pharmacy?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.