PLD Acquisitions LLC D/B/A Avema Pharma Solutions
Form 483 issued September 21, 2021 · Miami, Florida
- Inspection
- Sep 8 – Sep 21, 2021
- Investigators
- Jennifer Lalama· Teresa I. Navas
- Observations
- 7
- Pages
- 7
- FEI number
- 3000009210
In short: On September 21, 2021, FDA issued a Form 483 with 7 observations to PLD Acquisitions LLC D/B/A Avema Pharma Solutions in Miami, Florida (FEI 3000009210) after an inspection that ran Sep 8 – Sep 21, 2021. The investigators were Jennifer Lalama and Teresa I. Navas. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 5 of 7 observations.
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 objectionable microorganisms in drug products not required to be sterile are not…
- 02
Input to and output from the computer and records or data are…
- 03
Established test procedures and laboratory control…
- 04
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the…
This inspection in context
Jennifer Lalama
31 documents · 2015–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Florida.
The firmPLD Acquisitions LLC D/B/A Avema Pharma Solutions history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PLD Acquisitions LLC D/B/A Avema Pharma Solutions?
FDA listed 7 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected PLD Acquisitions LLC D/B/A Avema Pharma Solutions?
Jennifer Lalama and Teresa I. Navas are named on this Form 483, for the inspection of Sep 8 – Sep 21, 2021. Each investigator has a profile showing what they cite most.
When was PLD Acquisitions LLC D/B/A Avema Pharma Solutions inspected by FDA?
The inspection ran Sep 8 – Sep 21, 2021, and the Form 483 is dated September 21, 2021.
How do I get the full Form 483 for PLD Acquisitions LLC D/B/A Avema Pharma Solutions?
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.