FDA Intel

PCI San Diego, Inc.

Form 483 issued March 22, 2019 · San Diego, California

Observations
3
Pages
1
FEI number
3004575449

In short: On March 22, 2019, FDA issued a Form 483 with 3 observations to PCI San Diego, Inc. in San Diego, California (FEI 3004575449). Most observations concern quality system and facilities & equipment.

At a glance

2 of 3 observations on this 483 concern quality system.

Quality system2
Facilities & equipment1

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

  1. 01
    21 CFR 211.192

    Inadequate deviation…

  2. 02
    21 CFR 211.22

    Lack of quality control…

  3. 03
    21 CFR 211.67

    Failure to perform clean hold time studies of the system(b) (4) that has an expiration time…

The full 483

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

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This inspection in context

The firm

PCI San Diego, Inc. history

All 13 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.192

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at PCI San Diego, Inc.?

FDA listed 3 observations on this Form 483, mostly about quality system and facilities & equipment. The opening words of each observation are shown on this page.

When was PCI San Diego, Inc. inspected by FDA?

This Form 483 is dated March 22, 2019.

How do I get the full Form 483 for PCI San Diego, Inc.?

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