Inspections, Compliance, Enforcement, and Criminal Investigations


Medicated Premixes

  1. Investigational Samples (INV Samples)
    To demonstrate suspected drug carryover or other chemical contamination during manufacturing, collect 1-900 g (2 lbs) of static residual material in the equipment, and the finished product premixes.
  2. Official Physical Samples 702(b) [21U.S.C.372(b)] Portion Included
    For expensive premixes or components, collect a total of 3/170 gm(6 oz) subs; One sub from each of 3 containers. In the case of premixes packaged in plastic; e.g., mini-packs, follow instructions under bagged premixes.
    1. Bagged Premixes
      Collect 10 - 454 g (1 lb) subs from each lot. Sample all bags in lots under 10 bags, for a total of 10 subs from the lot.
      Collect 454 g (1 lb) subs from at least 10 different bags selected at random in lots of more than 10 bags.
    2. Bulk Premixes
      Collect at least 10 - 454 g (l lb) subs, from different locations in the lot providing a minimum total sample of 4.5 Kg (10 lbs).
  3. Documentary Samples (DOC Sample) - Refer to IOM for guidance on the collection of DOC Samples.

Medicated Feeds

  1. Investigational Samples (INV Sample)
    Collect 1 - 900 g (2 lb) of static residual material in the equipment and correlate with finished feed samples to show that residues are being carried over into the finished product.
  2. Official Samples (Includes 702(b) portion)
    1. Bagged Complete Feed
      Collect a total sample of not less than 2.3 kg (5 lbs) from each lot. Collect 454 g (1 lb) subs sampling all available bags from lots of 10 bags or less. If lot size is greater than 10 bags, collect 454 g (1 lb) from each of 10 bags selected at random.
    2. Bulk Complete Feed
      Collect at least 10 - 454 g (1 lb) subs from different points in the bulk lot to obtain a minimum total sample of 4.5 kg (10 lbs).
    3. Concentrates/Supplements
      If the concentrate or supplement is relatively inexpensive, follow the sampling procedures for complete feeds. Limit sampling of more expensive drug materials, concentrates, or supplements to no more than 3 containers taking a 170 g (6 oz) or 6 fl. oz. sub from each of the 3 containers.
  3. Documentary Samples (DOC Sample)
    1. Feed Subject to MFA Approval - Collect DOC Samples of products processed without required MFA approval. Where the plant does not ship in IS commerce, but ingredients are received from IS sources, document the IS nature of drug ingredients and the "Held For Sale" status of the finished feed. Labeling of drug ingredients must be submitted.
    2. Misbranded Products - Collect a DOC Sample for misbranding or labeling deficiencies. The failure to provide warning and/or withdrawal statements which could present danger to animals or man, or gross evidence of false and misleading therapeutic claims, are factors for consideration.

Sampling Precautions (See IOM Sample Schedule Chart 4)

  1. Insert the trier the full length of the bag when sampling bagged premixes, or complete feeds.
  2. Clean trier between sampling the different lots of premixes or complete feeds.
  3. Place subs in a clean, airtight container, preferably clean glass jars.
  4. Do not fumigate samples intended for potency analysis, drug carryover or cross-contamination.

Sample Submission

Submit samples to your district's servicing laboratory or as directed by your assignment or supervisor. See IOM

Page Last Updated: 07/28/2015
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