Pharm D Solutions, LLC
Form 483 issued August 28, 2018 · Houston, Texas
- Inspection
- Aug 13 – Aug 28, 2018
- Investigators
- Eileen A. Liu· Tracy K. Li
- Observations
- 16
- Pages
- 23
- FEI number
- 3011043554
In short: On August 28, 2018, FDA issued a Form 483 with 16 observations to Pharm D Solutions, LLC in Houston, Texas (FEI 3011043554) after an inspection that ran Aug 13 – Aug 28, 2018. The investigators were Eileen A. Liu and Tracy K. Li. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of dmg products pm-porting to be sterile are not…
- 02
EMPl.OYEE(S) SIGNATURE The quality control unit lacks the responsibility and authority to approve and reject all…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Each batch of drng product pruporting to be sterile is not laboratory tested to detennine confonnance…
This inspection in context
Eileen A. Liu
41 documents · 2014–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmPharm D Solutions, LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharm D Solutions, LLC?
FDA listed 16 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Pharm D Solutions, LLC?
Eileen A. Liu and Tracy K. Li are named on this Form 483, for the inspection of Aug 13 – Aug 28, 2018. Each investigator has a profile showing what they cite most.
When was Pharm D Solutions, LLC inspected by FDA?
The inspection ran Aug 13 – Aug 28, 2018, and the Form 483 is dated August 28, 2018.
How do I get the full Form 483 for Pharm D Solutions, LLC?
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.