FDA Intel

All Pharma, LLC

Form 483 issued November 15, 2019 · Hialeah, Florida

Inspection
Nov 4 – Nov 15, 2019
Investigator
Jennifer Lalama
Observations
5
Pages
5
FEI number
3010047167

In short: On November 15, 2019, FDA issued a Form 483 with 5 observations to All Pharma, LLC in Hialeah, Florida (FEI 3010047167) after an inspection that ran Nov 4 – Nov 15, 2019. The investigator was Jennifer Lalama. Most observations concern quality system and materials.

At a glance

Quality system and materials account for 3 of 5 observations.

Quality system2
Materials1
Production1
Facilities & equipment1

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 211.22(d)

    The responsibilities and procedures applicable to the quality control unit…

  2. 02
    21 CFR 211.84(a)

    Each lot of components is not withheld from use until the lot has been sampled, tested…

  3. 03
    21 CFR 211.192

    There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…

  4. 04
    21 CFR 211.100(a)

    Changes to written procedures are not drafted, reviewed and approved by…

1 more observation

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The investigator

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 firm

All Pharma, LLC history

The site's inspection history, in date order.

Similar 483s

Other sites cited under 211.22(d)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at All Pharma, LLC?

FDA listed 5 observations on this Form 483, mostly about quality system, materials and production. The opening words of each observation are shown on this page.

Who inspected All Pharma, LLC?

Jennifer Lalama is named on this Form 483, for the inspection of Nov 4 – Nov 15, 2019. Each investigator has a profile showing what they cite most.

When was All Pharma, LLC inspected by FDA?

The inspection ran Nov 4 – Nov 15, 2019, and the Form 483 is dated November 15, 2019.

How do I get the full Form 483 for All Pharma, LLC?

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