Pharm D Solutions, LLC
FDA inspection history in Houston, Texas, 2015 to 2018
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2015: one Form 483; 2016: one warning letter; 2018: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–18Two Form 483s and one warning letter, at Houston, Texas.
- 2018The longest 483 on file: 16 observations over 23 pages at Houston, Texas.
Cited most
Across all Pharm D Solutions observations on file
- 21 CFR 211.42Design and construction features6
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.188Batch production and control records3
- 21 CFR 211.167Special testing requirements2
- 21 CFR 211.100(a)Written procedures; deviations1
The complete Pharm D Solutions file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Houston, Texas
Two Form 483s and one warning letter · 2015 to 2018 · 24 observations
Latest: Form 483, Aug 28, 2018 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-08-28 | 483 Form 483 | Houston, Texas | 16 | $99 |
| 2016-12-08 | Warning letter Warning letter | Houston, Texas | — | $99 |
| 2015-06-05 | 483 Form 483 | Houston, Texas | 8 | $99 |
Investigators on these documents
FEI number 3011043554 · most recent document Aug 28, 2018
About Pharm D Solutions, LLC
How many FDA Form 483s has Pharm D Solutions, LLC received?
FDA Intel has 2 Form 483s on file for Pharm D Solutions, LLC; the most recent is dated Aug 28, 2018.
When was Pharm D Solutions, LLC last inspected by FDA?
The most recent FDA inspection document on file for Pharm D Solutions, LLC is a Form 483 dated Aug 28, 2018, for the site in Houston, Texas.
What did FDA cite at Pharm D Solutions, LLC?
The regulations cited most in the observations on file for Pharm D Solutions, LLC are 21 CFR 211.42 (Design and construction features), 6 times; 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.188 (Batch production and control records), 3 times.
Has Pharm D Solutions, LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Pharm D Solutions, LLC; the most recent is dated Dec 8, 2016.